Back Revised general chapters for elemental analysis published in Pharmeuropa 37.2

EDQM Strasbourg, France 14/04/2025
  • Diminuer la taille du texte
  • Augmenter la taille du texte
  • Imprimer la page
  • Imprimer en PDF
Revised general chapters for elemental analysis published in Pharmeuropa 37.2

Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters:

  • 2.2.22. Atomic emission spectrometry;
  • 2.2.23. Atomic absorption spectrometry;
  • 2.2.57. Inductively coupled plasma-atomic emission spectrometry;
  • 2.2.58. Inductively coupled plasma-mass spectrometry.

These analytical procedures are essential for ensuring the quality and safety of medicinal products and their ingredients, as well as other articles described in Ph. Eur. monographs, through the quantitation of elements. The four general chapters have been revised and are presented in Pharmeuropa 37.2 for comment because similar recommendations and quality requirements ultimately apply to all of them and this was not previously reflected in their content and structure.

The revision process was also driven by the content of the ICH Q3D Guideline and the requirements of Ph. Eur. general chapter 2.4.20. Determination of elemental impurities, neither of which was in place when the four Ph. Eur. general chapters on elemental analysis were first published.

The main objective of the revision is to harmonise the four texts along the following aspects, thus providing greater clarity to the application of the analytical procedures:

  • equipment performance;
  • sample preparation;
  • system suitability;
  • validation requirements.

Users are encouraged to comment on the four texts in Pharmeuropa 37.2, viewing them as a package and considering whether a comment on one of them applies to the others as well.